TriangleNCT02421939 · OUTCOME
Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From the date of randomization up to at least 6 months
What was measured
CRh rate was defined as the number of participants who achieved CRh at any of the postbaseline visits and did not have a best response of CR divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR at a post-baseline visit, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10\^9/L and platelet count ≥ 100 x 10\^9/L and normal marrow differential with \< 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. CRh: At a post baseline visit, participantss were classified as CRh if they had marrow blasts \< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\^9/L and platelets ≥ 50 x 10\^9/L, no evidence of extramedullary leukemia and could not be classified as CR.
Analysis population: The analysis population was the ITT.
Groups in this outcome
Gilteritinib
Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
Salvage Chemotherapy
Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
| Group | Source count |
|---|---|
| Gilteritinib | 247 |
| Salvage Chemotherapy | 124 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Gilteritinib | 34.0 | Not reported | 28.1 | 40.3 | Not reported |
| Salvage Chemotherapy | 15.3 | Not reported | 9.5 | 22.9 | Not reported |
Source statistical analyses
- ci Lower Limit
- 9.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 27.4
- group Description
- Based on a stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Pooled strata were used as shown in Table 12.3.3.2. Treatment differences were adjusted based on pooled strata. Treatment difference = gilteritinib 120 mg - chemotherapy.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0171
- p Value Comment
- Stratified 1-sided P-value.
- param Type
- Adjusted Treatment Difference,
- param Value
- 18.6
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- ci Lower Limit
- 9.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 27.4
- group Description
- Based on a stratified Cochran-Mantel-Haenszel test. Stratification factors were response to first-line AML therapy and preselected salvage chemotherapy per IRT. Pooled strata were used as shown in Table 12.3.3.2. Treatment differences were adjusted based on pooled strata. Treatment difference = gilteritinib 120 mg - chemotherapy.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- <0.0171
- p Value Comment
- Stratified 1-sided P-value.
- param Type
- Adjusted Treatment Difference,
- param Value
- 18.6
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 28.1
- upper Limit
- 40.3
- value
- 34.0
- group Id
- OG001
- lower Limit
- 9.5
- upper Limit
- 22.9
- value
- 15.3
- denoms
- counts
- group Id
- OG000
- value
- 247
- group Id
- OG001
- value
- 124
- units
- Participants
- description
- CRh rate was defined as the number of participants who achieved CRh at any of the postbaseline visits and did not have a best response of CR divided by the number of participants in the analysis population. CR: For participants to be classified as being in CR at a post-baseline visit, they must have had bone marrow regenerating normal hematopoietic cells and achieved a morphologic leukemia-free state and must had an ANC ≥ 1 x 10\^9/L and platelet count ≥ 100 x 10\^9/L and normal marrow differential with \< 5% blasts, and they were RBC and platelet transfusion independent (defined as 1 week without RBC transfusion and 1 week without platelet transfusion). There was no evidence of extramedullary leukemia. CRh: At a post baseline visit, participantss were classified as CRh if they had marrow blasts \< 5%, partial hematologic recovery ANC ≥ 0.5 x 10\^9/L and platelets ≥ 50 x 10\^9/L, no evidence of extramedullary leukemia and could not be classified as CR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 120 mg dose (3 tablets of 40 mg) orally once a day in continuous 28-day cycles, at least 2 hours after or 1 hour before food. Gilteritinib treatment continued until participants met one of the treatment discontinuation criteria. After the end of treatment period, participants were allowed to enter long-term follow up period for up to 3 years for collection of subsequent AML treatment, EuroQol Group-5 Dimension-5 Level Instrument (EQ-5D-5L), remission status and survival (cause of death and date of death). Participants continuing to derive clinical benefit from gilteritinib as assessed by the investigator were allowed to continue the study treatment until a discontinuation criterion was met or if they had completed more than 3 years of treatment.
- id
- OG000
- title
- Gilteritinib
- description
- Participants received chemotherapy in 28-day cycles. Participants on Low-Dose Cytarabine (LoDAC) received 20 mg of cytarabine twice daily by subcutaneous (SC) or intravenous (IV) injection for 10 days. Participants on azacitidine received 75 mg/m\^2 daily by SC or IV injection for 7 days. Participants on LoDAC or azacitidine treatment continued until they met discontinuation criteria. Participants on mitoxantrone, etoposide and intermediate-dose cytarabine (MEC) chemotherapy received mitoxantrone 8 mg/m\^2 daily by IV for 5 days, etoposide 100 mg/m\^2 daily by IV for 5 days and cytarabine 1000 mg/m\^2 daily by IV for 5 days (days 1-5). Participants on fludarabine, cytarabine and granulocyte colony-stimulating factor with idarubicin (FLAG-IDA) chemotherapy received granulocyte-colony stimulating factor (G-CSF) 300 μg/m\^2 daily by SC/IV for 5 days (days 1-5), fludarabine 30 mg/m\^2 daily by IV for 5 days (days 2-6), cytarabine 2000 mg/m\^2 daily by IV for 5 days (days 2-6) and idarubicin 10 mg/m\^2 daily by IV for 3 days (days 2-4). Participants receiving MEC or FLAG-IDA received 1 cycle of therapy and were assessed for response on or after day 15. After the end of treatment period, participants were allowed to enter the long-term follow-up period of up to 3 years for collection of subsequent AML treatment, EQ-5D-5L, remission status and survival (cause of death and date of death).
- id
- OG001
- title
- Salvage Chemotherapy
- param Type
- NUMBER
- population Description
- The analysis population was the ITT.
- reporting Status
- POSTED
- time Frame
- From the date of randomization up to at least 6 months
- title
- Percentage of Participants With Complete Remission (CR) With Partial Hematological Recovery (CRh)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice